Lannett Receives FDA Approval for Dorzolamide HCL with Timolol
19 December 2014 - 5:20AM
Business Wire
Lannett Company, Inc. (NYSE: LCI) today announced that it has
received approval from the U.S. Food and Drug Administration (FDA)
of its Abbreviated New Drug Application (ANDA) for Dorzolamide
Hydrochloride and Timolol Maleate Ophthalmic Solution, 2%/0.5%, the
therapeutic equivalent to the reference listed drug, Cosopt®
Ophthalmic Solution, 2%/0.5%, of Oak Pharmaceuticals, Inc..
According to IMS, for the year ended October 2014 total sales of
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution,
2%/0.5%, at Average Wholesale Price (AWP) were approximately $123
million.
“Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic
Solution, 2%/0.5%, adds a new dosage form to our product offering,”
said Arthur P. Bedrosian, chief executive officer of Lannett. “The
addition of this product exemplifies our team’s capabilities to
develop and manufacture medications in a wide variety of forms,
including solid orals in both immediate and extended release,
topicals, oral solutions, parenterals and now ophthalmics. This
approval represents our fourth product approved by the FDA thus far
in fiscal 2015. We expect to commence shipping the product in the
coming months.”
About Lannett Company, Inc.:
Lannett Company, founded in 1942, develops, manufactures,
packages, markets and distributes generic pharmaceutical products
for a wide range of medical indications. For more information,
visit the company’s website at www.lannett.com.
This news release contains certain statements of a
forward-looking nature relating to future events or future business
performance. Any such statement, including, but not limited to,
successfully commercializing Dorzolamide Hydrochloride and Timolol
Maleate Ophthalmic Solution, 2%/0.5%, and the receipt of product
approvals in coming months, whether expressed or implied, is
subject to market and other conditions, and subject to risks and
uncertainties which can cause actual results to differ materially
from those currently anticipated due to a number of factors which
include, but are not limited to, the risk factors discussed in the
Company’s Form 10-K and other documents filed with the SEC from
time to time, including the prospectus supplement related to the
proposed offering to be filed with the SEC. These forward-looking
statements represent the Company's judgment as of the date of this
news release. The Company disclaims any intent or obligation to
update these forward-looking statements.
Robert Jaffe Co., LLCRobert Jaffe, (424) 288-4098
Lannett (NYSE:LCI)
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